U.S. EPA, Pesticide Product Label, REGENT 4SC INSECTICIDE, 06/13/2008
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'/ (1 UNITED STATES ENVIRUNMENTAL PROTECTIUN AGENCY . WASHINGI'ON. D.C l\14(\D (IFI'I(T(lI· 1'f{I':VI::NIION. I'(SII( ·1f)E~ I\Nf) T( IXIC' SlIBST;\NCI'.S JUN 1 a JJJ'OS Mr. Dave G. Bolin Product Registration Manager US Regulatory Affairs BASF Corporation, Agricultural Products P.O. Box 13528 Research Triangle Park, NC 27709-3528 RE: Notification of additional text added to Supplement Label EPA Registration Number: ·7969-207 Date of Submission: April 22, 2008 Dear Mr. Bolin: The Agency is in receipt of your Application for Pesticide Notification under Pesticide Registration Notice (PRN) 98-10 dated April 22, 2008, for the product Regent 4SC Insecticide). The Registration Division (RD) has conducted a review of this request for its applicability under PRN 98-10 and finds that the actions requested fall within the scope ofPRN 98-10. The label submitted with the application has been stamped "Notification" and will be placed in our records.· If you have any questions, please call me directly at 703-0305-6249 or Joyce Edwards of my staff at 703-308-5479. Sincerely, (-:/"""\....--. Linda Arrington Notifications & Minor Formulations Team Leader Registration Division (7505P) Office of Pesticide Programs . PI.UtI ,..ill".tnK:tio", tIIJ ",,,.,.. H/olfl comllltdintl form. Form ADDroved, OMB No... "' .. " "".. , '&AA.A--I .mir_ ~.~8.95 United States ~ Registration opp Identifiar Number &EPA Environmental Protection Agency Amendment Washington, DC 20460 .; Other Application for Pesticide - Section I 1 . CompanyfProduct Number 2. EPA Product Manager 3. Proposed Classification 7969-207 Richard Gebken . DNone [{] Restricted 4. Company/Product (Name) PM' REGENT 4SC Insecticide 10 5. Neme and Address of Applicant (Include ZIP Code) 6. Expedited Reveiw. In accordance with FIFRA Section 31c)(31 BASF Corp. Agricultural Products PO Box 13528 IbHil. my product is similar or identical in composition and labeling Research Triangle Park. NC 27709-3528 to: EPA Reg. No. o Check if this is B new address Product Name Section - II Amendment· Explain below. Final printed labels in repsonse to D U Agency letter dated 0 Rasubmission in response to Agency letter dated 0 wMe Toow Application. NOTiFICATION 0 Notification - Explain below. 0 Other - Explain balow. JUN 182008 Explanation: Use additional pagels) jf necessBry. (For section I and Section II.) Notification of additional text added to Supplemental Label. Text states "Regent4SC is not registered for in-furrow use on potatoes in New York state." Text is consistent with the Notification criteria as described under PR Notice 98-10. No PRIA fee is associated with this action. Section - III 1. Material Thle Product Will Be Packaged In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ot Container Yes ~yes ~yes ,/ Plastic .; No .; No No ~M'~ ~ Glass If wYes· No. par If ·Yesw No. per Paper • C8rtification must Unit Packeging wgt. conteiner Package wgt container Other (Specify) be submitted I 3. Location of Net Contents Information 4. Size(s) Retail Conteiner 15. loc.etion cif label Directions on label ({: Label U Container including but not limited to 104 oz. t::=:3 6. Manner in Which Label is Affixed to Product Uthograph Other t:j. Papar p'!Ued 0 Stenci 8d Section - IV 1. Contact Point (Complete items directly below for identificBtion of individuBl to be contacted, if necessary, to procflSS this application.) Name Title Telephone No. (Include Area Code I Dave G. Bolin Product Registration Manager 919-547-2108 Certification 6. Date Application I certify that the statements I have made on this form and all attachments thereto are true. accurate and complete. Received '.' (~ '- ( I acknowledge that any knowlinglly false or misleading statement may be punishable by fine or imprisolVnent 01' '.' . : \. (£6mped) both under applicable law. ' v '. ' (/ 3. TItle ' "t. I' . 't". (. 2.Si.M,""~ (. ,. c· '.' ( . Product Registration Manager >.' . ., .. " ifJ~ ... '. ", -.-.- '_.'.. , 4. Typed.Name 5. Date ( :. '- '- Dave G. Bolin '.. April 22, 2008 v t.. 1...', ' . EPA Form 8570·' (Rev. 3·941 Previous editions are obsolete. White • EPA FiJe Copy (origin." . " ~BASF The Chemical Company Agricultural Products Document Processing Desk (NOTIF) Office of Pesticide Programs (7504C) U.S. Environmental Protection Agency June 17, 2008 One Potomac Yard 2777 S. Crystal Drive Arlington, Virginia 22202 Re: Notification of Supplemental Labeling for REGENT® 4SC (EPA Reg. No. 7969-207) Dear Notificatipn Team, BASF is hereby submitting an updated Supplemental Label for Regent 4SC Insecticide. The label is for in-furrow use on potatoes. This label supersedes the Supplemental Label submitted March 19, 2008. The text below was added to the label. BASF believes that this change is consistent with the Notification criteria as described under PR Notice 98-10. A statement regarding buffers in New York state was also removed. This was done to eliminate any confusion about this use in New York state on potatoes. No other changes have been made to the label text. "Regent 4SC is not registered for in-furrow use on potatoes in New York State." Attached to support this submission are two copies of Supplemental Label, completed EPA Form 8570-1; copy ofthe previous notification and EPA letter. Please feel free to contact me (919-547-2108 / [email protected]) if you have any questions This notification is consistent with the provisions of PR Notice 98-10 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the Jabeling or the confidential statement of formula ofthis product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand tlIat if this notification is not consistent with the terms of PR Notice 98-10 and 40 CFR 152.46, this product may be in violation ofFIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 ofFIFRA. Respectfully Submitted, Dave G. Bolin Product Registration Manager - U.S. Regulatory Affairs @) Registered Trademark of BASF BASF Corporation Agricultural Products 26 Davis Drive Research Triangle Park. NC 27709 Tel: (800) 669-1770 . y.NIW.agprodllcts.basf.com a-BASF fNiOnlFlCATDON The Chemical Company JUN 132008 RESTRICTED USE PESTICIDE DUE TO TOXICITY TO AQUATIC INVERTEBRATES For retail sale to and use only by Certified Applicators or persons under their direct supervision, and only for those uses covered by the Certified Applicator's certification. REGENT®4 SC Supplemental Label INSECTICIDE For In-Furrow Use on Potatoes Shake Well Before Use EPA Reg. No. 7969·207 Active Ingredient: Fipronil: 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)- 4((1 ,R,S)-(trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile ........... ....................................................... 39.4% Other Ingredients: ...... ........................ ............................................... ...... ...... ..... .................................. 60.6% Total: ......................................................................................................................................................... 100.0% One gallon Regent® 4 SC insecticide contains 4 Ibs fipronil. DIRECTIONS FOR USE RESTRICTED USE PESTICIDE It is a violation of federal law to use this product in a manner inconsistent with its labeling. Read entire label before using this product. DO NOT apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application. For any requirements specific to your state or tribe, consult the agency responsible for pesticide regulation. Refer to the Regent 4 SC container label, EPA Reg. No. 7969-207, for complete Directions For Use and all applicable restrictions and precautions. User must have the full Regent 4 SC container label and this supplemental label in possession at the time of pesticide application. BASF Corporation \ I, _. 26 Davis Drive, Research Triangle Park, NC 27709 GENERAL PRECAUTIONS AND USE RESTRICTIONS INSTRUCTIONS • DO NOT apply this product through any kind of irrigation system. SPRAY PREPARATION • DO NOT harvest within 90 days of application. Remove oil, rust, scale, pesticide residues and foreign matter from sprayer and strainer. Flush with clean • DO NOT plant root, leafy, or legume vegetables water. Use 50 mesh screens or equivalent in spray within four months following application. system. Applicator tanks must be equipped with a • DO NOT plant wheat or triticale within two months sparge tube agitator, unless the alternative agitator following application. designs can adequately cleanse the bottom of the tank • DO NOT plant any other rotational crops (except and provide sufficient agitation required for product . field corn, potato, leafy vegetables, root vegetables, mixing. Pump approximately 10% of the tank capacity legume vegetables, wheat, or triticale) within 12 per minute back into the tank through the agitator. months following application. To prepare for spraying, fill tank to approximately Regent 4 SC is not registered for in-furrow 1/2 the needed volume of water or liquid fertilizer and start agitation. Open product container(s) and pour use on potatoes in New York State. contents into tank. Agitate to ensure thorough mixing Observe the following precautions when applying in for a minimum of 2 minutes or until product is the vicinity of aquatic areas: DO NOT apply within thoroughly dispersed. Agitate product mixtures 20 yards of lakes, reservoirs,